The Detection Of Circulating Tumor Cells (CTC) In Patients With NSCLC Undergoing Definitive Radiotherapy Or Chemoradiotherapy

NCT02135679 | Completed Results DMC

• 1 other identifier: UPCC 12512
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

CTC levels collected pre-surgery will be correlated with pathological samples.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• To Describe the Pattern of CTCs Before and After Definitive Radiotherapy for Each Treatment Stratum

  The pattern of CTCs before and after definitive radiotherapy for each treatment stratum. CTC counts per mL before and after definitive radiotherapy.

  24 months

Study Arms (7)

Cohort 1

Patients with early stage NSCLC undergoing stereotactic radiotherapy

Radiation: Radiotherapy

Cohort 2

Patients with locally advanced NSCLC undergoing standard chemoradiotherapy

Radiation: Radiotherapy

Cohort 3

Patients with stage I-III NSCLC undergoing standard, fractionated radiotherapy alone

Radiation: Radiotherapy

Cohort 4

Patients with locally advanced NSCLC undergoing standard chemoradiotherapy with the novel signal transduction inhibitor, nelfianvir.

Radiation: Radiotherapy

Cohort 5

Patients with resectable stage IIIa NSCLC undergoing pre-operative chemoradiotherapy

Radiation: Radiotherapy

Cohort 6

Patients with suspected (no tissue diagnosis) early stage NSCLC undergoing stereotactic radiotherapy

Radiation: Radiotherapy

Cohort 7

Patients with locally advanced NSCLC undergoing stereotactic radiotherapy followed by concurrent mediastinal chemoradiotherapy

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

NSCLC patients

You may qualify if:

• Patients with biopsy-proven NSCLC who are undergoing definitive radiotherapy as a part of their treatment regimen.
• Age 18 or older
• Signed informed consent
• Patients who are incapable of providing informed consent are excluded from participating in this study.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Evanson D, Griffin M, O'Reilly SE, Johnson T, Werner T, Kothekar E, Jahangiri P, Simone CB 2nd, Swisher-McClure S, Feigenberg SJ, Revheim ME, Zou J, Alavi A. Comparative assessment of radiation therapy-induced vasculitis using [18F]FDG-PET/CT in patients with non-small cell lung cancer treated with proton versus photon radiotherapy. Eur J Nucl Med Mol Imaging. 2024 Apr;51(5):1444-1450. doi: 10.1007/s00259-023-06535-3. Epub 2023 Dec 14.

  PMID: 38095673 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Ching Lai
• Organization: University of Pennsylvania

ching.lai@pennmedicine.upenn.edu

267-250-9244

Study Officials

• Steven Feigenberg, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2014
• First Posted: May 12, 2014
• Study Start: September 1, 2012
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2021
• Last Updated: November 20, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-11

Locations

US (1)